(120 days)
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).
The HI-TOROUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
The HI-TOROUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study
The study, named "EXPERT CTO Guidewire Clinical Trial," was a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT PILOT guide wires in recanalization of chronic total occlusions (CTO).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Primary Endpoint) | Lower Bound of One-Sided 95% CI | P-value |
|---|---|---|---|
| 62.5% | 79.0% (109/138 successful recanalizations) | 72.8% |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.